Uses For Proventil

Albuterol is used to treat or prevent bronchospasm in patients with asthma, bronchitis, emphysema, and other lung diseases. This medicine is also used to prevent wheezing caused by exercise (exercise-induced bronchospasm).

Albuterol belongs to the family of medicines known as adrenergic bronchodilators. Adrenergic bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

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This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, albuterol is used in certain patients with the following medical condition:

Hyperkalemia (too much potassium in the blood).

Before Using Proventil

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of albuterol inhalation aerosol (eg, Proair® HFA) in children 4 years of age and older, albuterol inhalation powder (eg, Proair® Respiclick™) in children 12 years of age and older, and albuterol inhalation solution (eg, Accuneb®) in children 2 years of age and older. However, safety and efficacy have not been established for the albuterol inhalation aerosol in children younger than 4 years of age, albuterol inhalation powder in children younger than 12 years of age, and albuterol inhalation solution in children younger than 2 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of albuterol inhalation aerosol (eg, Proair® HFA) and albuterol inhalation powder (eg, Proair® Respiclick™) in geriatric patients. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require caution and an adjustment in the dose for patients receiving albuterol inhalation aerosol and albuterol inhalation powder.

No information is available on the relationship of age to the effects of albuterol inhalation solution (eg, Accuneb®) in geriatric patients.

Pregnancy

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol

Amineptine

Amitriptyline

Amitriptylinoxide

Amoxapine

Atenolol

Atomoxetine

Befunolol

Betaxolol

Bevantolol

Bisoprolol

Bopindolol

Carteolol

Carvedilol

Celiprolol

Clomipramine

Desipramine

Dibenzepin

Doxepin

Esmolol

Furazolidone

Imipramine

Iobenguane I 123

Iproniazid

Isocarboxazid

Labetalol

Landiolol

Levalbuterol

Levobunolol

Linezolid

Lofepramine

Melitracen

Mepindolol

Methylene Blue

Metipranolol

Metoprolol

Moclobemide

Nadolol

Nebivolol

Nipradilol

Nortriptyline

Opipramol

Oxprenolol

Pargyline

Penbutolol

Phenelzine

Pindolol

Procarbazine

Propranolol

Protriptyline

Rasagiline

Selegiline

Sotalol

Talinolol

Tertatolol

Tianeptine

Timolol

Tranylcypromine

Trimipramine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Allergy to milk proteins, history or—Proair® Respiclick™ should not be used in patients with this condition.

Diabetes or

Heart or blood vessel disease or

Heart rhythm problems (eg, arrhythmia) or

Hypertension (high blood pressure) or

Hyperthyroidism (overactive thyroid) or

Hypokalemia (low potassium in the blood) or

Seizures, history of—Use with caution. May make these conditions worse.

Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of albuterol

This section provides information on the proper use of a number of products that contain albuterol. It may not be specific to Proventil. Please read with care.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine or any asthma medicine without telling your doctor. To do so may increase the chance for breathing problems.

The albuterol inhalation solution (eg, Accuneb®) should be used with a jet nebulizer that is connected to an air compressor with good air flow. The inhalation solution and nebulizer will come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To use the inhalation solution in the nebulizer:

Use one container of solution or mix the exact amount of solution using the dropper provided for each dose.

Place the inhalation solution in the medicine reservoir or nebulizer cup on the machine.

Connect the nebulizer to the face mask or mouthpiece.

Use the face mask or mouthpiece to breathe in the medicine.

Use the nebulizer for about 5 to 15 minutes, or until the medicine in the nebulizer cup is gone.

Clean all the parts of the nebulizer after each use.

The albuterol inhalation aerosol (eg, Proair® HFA) and albuterol inhalation powder (eg, Proair® Respiclick™) is used with a special inhaler that comes with patient instructions. Read the directions carefully before using this medicine. If you or your child do not understand the directions or are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check you or your child on a regular basis to make sure you are using it properly.

To use the inhalation aerosol:

The inhaler should be at room temperature before you use it.

Insert the metal canister firmly and fully into the clear end of the Proair® HFA mouthpiece. This mouthpiece should not be used with other inhaled medicines.

Remove the cap and look at the mouthpiece to make sure it is clean.

Shake the inhaler well and test spray it in the air 3 times before using it for the first time or if the inhaler has not been used for more than 2 weeks.

To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece just in front of your mouth with the canister upright.

Open your mouth and breathe in slowly and deeply (like yawning), and at the same time firmly press down once on the top of the canister.

Hold your breath for about 10 seconds, then breathe out slowly.

If you are supposed to use more than one puff, wait 1 minute before inhaling the second puff. Repeat these steps for the second puff, starting with shaking the inhaler.

When you have finished all of your doses, rinse your mouth with water and spit the water out.

Clean the inhaler mouthpiece at least once a week with warm running water for 30 seconds, and dry it completely.

If you need to use the inhaler before it is completely dry, shake off the excess water, replace the canister, and spray it 2 times in the air away from the face. Use your regular dose.

After using the inhaler, wash the mouthpiece again and dry it completely.

If the mouthpiece becomes blocked, washing it will help.

To use the inhalation powder:

Take the inhaler from the foil pouch before you use it for the first time.

The inhaler provides about 200 inhalations. The dose counter will change to red when there are "20" doses left. Call your doctor or pharmacist for a refill of prescription or medicine.

Make sure the cap is closed before using this medicine. Do not open the cap unless you are going to use it.

Hold the inhaler upright as you open the cap fully until you hear a "click". Your inhaler is now ready to use.

To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it.

Breathe in through your mouth as deeply as you can until you have taken a full deep breath.

Do not block the vent above the mouthpiece with your lips or fingers.

Hold your breath for about 10 seconds or as long as you comfortably can.

Remove the inhaler from your mouth and check the dose counter to make sure you received the medicine.

Close the cap firmly over the mouthpiece after using the inhaler. Always close the cap after each use.

If you are supposed to use more than one puff, repeat these steps for the second puff, starting with opening the cap fully.

Keep the inhaler clean and dry at all times. Do not wash or put any part of the inhaler in water.

If you need to clean the mouthpiece, wipe it gently with a dry cloth or tissue.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For inhalation aerosol dosage form (inhaler):

For treatment or prevention of bronchospasm:

Adults, teenagers, and children 4 years of age and older—Two puffs every 4 to 6 hours as needed.

Children younger than 4 years of age—Use and dose must be determined by your child's doctor.

For prevention of exercise-induced bronchospasm:

Adults, teenagers, and children 4 years of age and older—Two puffs taken 15 to 30 minutes before exercise.

Children younger than 4 years of age—Use and dose must be determined by your child's doctor.

For inhalation powder dosage form (inhaler):

For treatment or prevention of bronchospasm:

Adults, teenagers, and children 12 years of age and older—Two puffs every 4 to 6 hours as needed.

Children younger than 12 years of age—Use and dose must be determined by your child's doctor.

For prevention of exercise-induced bronchospasm:

Adults, teenagers, and children 12 years of age and older—Two puffs taken 15 to 30 minutes before exercise.

Children younger than 12 years of age—Use and dose must be determined by your child's doctor.

For inhalation solution dosage form (used with a nebulizer):

For prevention of bronchospasm:

Adults and children older than 12 years of age—2.5 milligrams (mg) in the nebulizer 3 or 4 times per day as needed.

Children 2 to 12 years of age—0.63 to 1.25 mg in the nebulizer 3 or 4 times per day as needed.

Children younger than 2 years of age—Use and dose must be determined by your child's doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Proventil

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

This medicine should not be used together with other inhaled medicines that are similar, such as isoproterenol (Isuprel®), levalbuterol (Xopenex™), metaproterenol (Alupent®), pirbuterol (Maxair®), or terbutaline (Brethaire®).

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you or your child have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

Talk to your doctor or get medical help right away if:

Your symptoms do not improve or they become worse after using this medicine.

Your inhaler does not seem to be working as well as usual and you need to use it more often.

You or your child may also be taking an antiinflammatory medicine, such as a steroid (cortisone-like medicine), together with this medicine. Do not stop taking the antiinflammatory medicine, even if your asthma seems better, unless you are told to do so by your doctor.

Albuterol may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child develop a skin rash, hives, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you or your child have more than one of the following symptoms: convulsions, decreased urine, dry mouth, increased thirst, irregular heartbeat, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, shortness of breath, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

Proventil Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Fast, irregular, pounding, or racing heartbeat or pulse

shakiness in the legs, arms, hands, or feet

trembling or shaking of the hands or feet

Less common

Abdominal or stomach pain

bladder pain

bloody or cloudy urine

chest discomfort

chest pain

cough or hoarseness

cough producing mucus

diarrhea

difficult or labored breathing

difficulty with swallowing

dizziness

feeling of warmth

fever or chills

frequent urge to urinate

hives

itching

loss of appetite

lower back or side pain

nausea

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the face, neck, arms, and occasionally, upper chest

runny nose

shortness of breath

skin rash

sore throat

swollen, painful, or tender lymph glands in the neck, armpit, or groin

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

dry mouth

extra heartbeats

fainting

flushed, dry skin

fruit-like breath odor

hallucinations

headache

increased hunger

increased thirst

increased urination

irritability

lightheadedness

muscle pain or cramps

nervousness

nightmares

numbness or tingling in the hands, feet, or lips

pounding in the ears

rapid, deep breathing

restlessness

shakiness

slow or fast heartbeat

stomach cramps

sweating

unexplained weight loss

unusual feeling of excitement

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Body aches or pain

congestion

fever

runny nose

tender, swollen glands in the neck

trouble with swallowing

voice changes

Less common

Difficult, burning, or painful urination

earache

headache, severe and throbbing

muscle or bone pain

pain

redness of the skin

redness or swelling in the ear

redness, swelling, or soreness of the tongue

sleeplessness

sneezing

stuffy nose

swelling

tenderness

trouble in holding or releasing urine

trouble sleeping

unable to sleep

warmth on the skin

Rare

Sleepiness or unusual drowsiness

Incidence not known

Bad, unusual, or unpleasant (after) taste

change in taste

feeling of constant movement of self or surroundings

gagging

rough, scratchy sound to voice

sensation of spinning

tightness in the throat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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